Diversity of clinical trials: Sponsors seek clarification on data sources, timing
Posted on June 15, 2022 | By
Drugmakers and clinician organizations have welcomed the U.S. Food and Drug Administration’s (FDA) recent draft guidelines with recommendations on developing a racial and ethnic diversity plan to improve enrollment racial and ethnic groups underrepresented in clinical trials. But in public comments, they also asked for more details on the types of data that should be used to assess adequate recruitment of these populations, how these diversity plans should be applied to global clinical trials and more details on the timeline. submissions and plan updates. .
The FDA released the draft guidelines in April 2022, recommending that sponsors submit a racial and ethnic diversity plan with submissions of investigational new drugs (INDs), biologics license applications (BLAs), and drug waivers. experimental device (IDE). (RELATED: FDA recommends sponsors include race and ethnicity in clinical trial designRegulatory guidance April 13, 2022)
The orientation project advises sponsors to start with an evaluation of all data indicating a product’s potential to have “differential safety or efficacy associated with race or ethnicity.” However, drugmakers have stressed the need for more clarity on the types of data to use. “It’s not clear what ‘all data’ is meant to include. For example, does this refer to data on potential differences in drug safety and effectiveness associated with race and ethnicity due to biological factors alone, or is the intent to include data on all differences, including those due to behavioral or environmental factors? Pfizer wrote comments on the draft guidelines.
Amgen asked the FDA for examples of disease areas where race and ethnicity are known to impact drug safety and effectiveness and examples of disease-specific references to the breakdown of race and ethnicity. of ethnicity. “This information could also help promote a more consistent diversity strategy among sponsors, which would reduce potential operational biases in evaluating the benefit-risk assessment across therapeutic area and drug class,” said commented Amgen.
The Association of Clinical Research Organizations (ACRO) has asked the FDA to clarify the types of real-world data that can be used to set listing targets. “Real-world data is not always complete, especially for race and ethnicity. It will be important for the FDA to advocate for the completeness of real-world datasets,” the organization noted. .
The Cleveland Clinic suggested the FDA consider using genetic ancestry estimation to help characterize the differential effects of medical products, rather than self-declaration of race and ethnicity alone. . In terms of determining listing targets, Cleveland Clinics asked the FDA to clarify that these targets will be defined by a particular geography or the United States in general.
The Association of Community Cancer Centers (ACCC) Community Oncology Research Institute said the FDA should explicitly recommend that sponsors collect social determinants of health (SDOH) data as part of the diversity plan. . “Given the significant impact of SDOH on results and efficiency and the barriers these social factors can create in underrepresented racial and ethnic populations, we believe that sponsors should address SDOH in their plans and strive to document data on social needs throughout the development life cycle of the medical product,” commented Randall A. Oyer, MD, chair of the ACCC Community Oncology Research Institute Task Force.
Commentators also raised concerns about the sponsors’ ability to prepare the diversity plan at the End of Phase 2 (EOP2) meeting. Amgen noted that it made sense to discuss some elements of the diversity plan at the EOP2 meeting, but that part of the Phase 3 program, including feasibility and site selection, may not be complete. before later.
The Biotechnology Innovation Organization (BIO) also commented on the need to have clear expectations about what information should be submitted at different stages of development and when and how updates should be made to the diversity plan. BIO also asks for information on the duration of the review of the plan and its place in the file.
Global clinical trials
The drugmakers asked for more information about how the diversity plan recommendations, which refer to the underrepresentation of racial and ethnic groups in the U.S. population, would be applied in the context of global clinical trials. Pfizer noted that the draft guidelines do not explicitly state whether the diversity plan should focus on US data or global data. BIO recommended that the FDA convene public meetings with industry and others to discuss best practices for recruiting, enrolling, and retaining diverse patient populations in global clinical trials.
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